Health regulators in the U.K. have announced new contraindications and warnings regarding Rasilez (aliskiren), a blood pressure drug which is sold as Tekturna in the U.S. According a Drug Safety Update issued by the Medicine and Healthcare Products Regulatory Agency, the use of aliskiren in combination with two types of heart drugs called ACE inhibitors and Angiotensin II receptor blockers (ARB) is now contraindicated in type 1 and type 2 diabetics, as well as patients with kidney impairment.

Aliskiren was brought to market as Rasilez and Tekturna in 2007, and Novartis had high hopes that the drug would become a blockbuster. It is approved as a treatment for hypertension (high blood pressure) either as monotherapy or in combination with other medications. However, in December the company announced a clinical trial called ALTITUDE had been halted after an independent review committee noted higher adverse events in patients receiving Rasilez/Tekturna in addition to standard of care in the trial. There was also an increased incidence after 18-24 months of serious side effects in the high risk population, including non-fatal stroke, kidney complications, hyperkalemia (high potassium), and hypotension (low blood pressure). The ALTITUDE study was designed to evaluate the effect of aliskiren on the likelihood of cardiovascular and kidney events in high-risk diabetic patients.

As a precautionary measure, Novartis stopped promotion of the drug and combination products containing aliskiren in combination with an ACE inhibitor or ARB in December. In January, Novartis agreed to a request from European regulators to add new safety warnings to the labels of aliskaren products to reflect the findings of the ALTITUDE trial. Novartis also wrote to physicians world-wide recommending that patients with Type 2 diabetes shouldn’t be treated with aliskiren, or combination products containing aliskiren, if they are also receiving an ACE inhibitor or ARB.

In addition to contraindicating against the use of aliskaren in combination with ACE inhibitors or ARBs in diabetics and kidney patients, the MHRA also stated that the combination is not recommended in any other patients. Any use of aliskiren (either as monotherapy or in combination with other medicines) is no longer recommended in any patient with severe kidney impairment.

Prescribers in the U.K. have been advised to review the treatment of all patients taking aliskiren in combination with an ACE inhibitor or an ARB at a routine appointment. In patients who are taking an ACE inhibitor or an ARB, healthcare professionals should stop aliskiren and not initiate new treatment in diabetics or kidney patients. In all patients where aliskiren treatment is continued or initiated, kidney function and glucose tolerance should be monitored at appropriate intervals, the MHRA said.